FDA Medical Device Recalls (openFDA)
United Nuclear Scientific Supplies, LLC: United Nuclear Scientific High Power Handheld Lasers. Laser products
- Recall number
- Z-0051-2018
- Recalling firm
- United Nuclear Scientific Supplies, LLC
- Product
- United Nuclear Scientific High Power Handheld Lasers. Laser products
- Status
- Terminated
- Initiated
- 2016-08-25
- Posted
- not on file
- Terminated
- 2020-10-27
- Reason
- Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- United Nuclear will bring defect into compliance by : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving three units will consist of the following: 1. Notification will be given to purchasers per 21 CFR 1003.21. 2 .A full refund will be offered to all purchasers upon return of their laser pointers. 3. Postage paid shipping containers will be provided to all purchasers for the return of the laser pointers. Please note that United Nuclear Scientific Supplies, LLC is responsible for the correction of all noncompliant products If you have any questions, please call (517) 339-3587, or email : sales@unitednuclear.com
- Quantity
- 3
- Distribution
- US Distribution
- Lot, serial or model codes
- Surveying Leveling and Alignment (SLA) laser products
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REA
- Firm FEI
- 3013936624
- Firm city
- East Lansing
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28